Home / Recalls / Roche Diabetes Care, Inc. / Z-0997-2020

Z-0997-2020 Class II Terminated

Recalled by Roche Diabetes Care, Inc. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
February 12, 2020
Initiation Date
December 11, 2019
Termination Date
July 8, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82,332 vials

Product Description

Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001

Reason for Recall

Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

Distribution Pattern

Nationwide: Foreign: Austalia, India

Code Information

Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1

Other recalls by Roche Diabetes Care, Inc.

  • Z-2174-2024 Class II — Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh ca (May 13, 2024)
  • Z-1008-2022 Class II — RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. (March 9, 2022)
  • Z-2351-2021 Class II — Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: (July 28, 2021)
  • Z-2352-2021 Class II — Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 072 (July 28, 2021)
  • Z-2353-2021 Class II — Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: (July 28, 2021)
  • Z-2354-2021 Class II — Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05 (July 28, 2021)
  • Z-0999-2020 Class II — ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System (December 11, 2019)
  • Z-0998-2020 Class II — Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring (December 11, 2019)
  • Z-0747-2020 Class II — Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPL (September 30, 2019)
  • Z-0749-2020 Class II — Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER (September 30, 2019)